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Agfa N.V.

BE Last updated 23 Oct 2026

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Devices
4
Registries
FDA 510(k)FDA
FDA recalls
72 ongoing

Catalogue4

FDA recalls7

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2024

    • 29 Jul 2024 Z-2738-2024 Class II Ongoing Potential for the front lever chain of the DR 800 table to fail.
    • 23 Feb 2024 Z-1462-2024 Class II Ongoing Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm if the cable is cut off does not work properly, may result in patient injury

  • 2020

    • 6 Apr 2020 Z-2202-2020 Class II Terminated Under specific conditions (Fluoroscopic exam, ABS=OFF, manual change of parameters) wrong calculation of the dose/minute for fluoroscopy exams can be possible
    • 10 Feb 2020 Z-1502-2020 Class II Terminated Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.

  • 2019

    • 27 Jun 2019 Z-2056-2019 Class II Terminated The exposed area of fluo exams possibly does not match the active area of the detector within specified limits.
    • 25 Jan 2019 Z-1034-2019 Class III Terminated Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities

  • 2018

    • 15 Aug 2018 Z-3245-2018 Class II Terminated A supplier for the Agfa system noted a potential for the steel support cables of a similar device to break. This led to a mandatory review of all systems, changing the pulley and cables if any deterioration in the cables or irregular or excessive pulley wear. If the two cables that support the equipment to its roof anchor break, the equipment might fall and cause harm to the patient, or others.

What Agfa N.V. makes

Agfa N.V. manufactures digital radiography systems, including flat-panel detectors and tomosynthesis units for breast and general imaging. Their portfolio includes standalone detectors (e.g., XD Detectors) and integrated systems like the DR 800 and DR 600 series, designed for hospital and clinical use.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The company’s products are listed in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device authorisation requirements.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Agfa N.V. manufacture?

Agfa N.V. specialises in digital radiography systems, including standalone flat-panel detectors (like the XD Detectors) and integrated imaging solutions such as the DR 800 and DR 600 series. These systems are designed for both general radiography and tomosynthesis, particularly for breast imaging, catering to hospital and clinical environments.

Where is Agfa N.V. based, and does it operate in the United States?

Agfa N.V. is headquartered in Belgium, but it operates in the United States as a manufacturer of medical imaging devices. The company’s U.S.-based products are subject to FDA regulations, including classification and clearance requirements.

How are Agfa N.V.’s devices classified under FDA regulations?

Agfa N.V.’s medical devices, such as digital radiography systems and tomosynthesis units, fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, including 510(k) clearance for market authorisation.

Are Agfa N.V.’s devices listed in any regulatory registries?

Yes, Agfa N.V.’s devices are included in the FDA’s 510(k) database, which tracks medical devices that have received clearance through the 510(k) premarket submission process. This listing confirms compliance with U.S. regulatory requirements for their authorised products.

Why are Agfa N.V.’s digital radiography systems authorised through 510(k) clearances?

The 510(k) clearance process is required for Class II devices like Agfa N.V.’s radiography systems because they are not considered low-risk (Class I). The FDA mandates this pathway to demonstrate that new or modified devices are substantially equivalent to legally marketed predicates—ensuring they meet performance, safety, and effectiveness standards before commercialisation.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
BE
Address
Septestraat 27, Mortsel Antwerpen
FDA FEI number
3001556265